品質系統經(副)理 Quality Systems (Assistant) Manager
面議（經常性薪資達4萬元或以上） 40000元
南投縣南投市
10~11年工作經驗
OVERALL OBJECTIVES:
-Provide leadership and oversight of designated GxP Computerized Systems (that have are relevant for Lotus Pharmaceutical) and their support teams to ensure successful delivery of key objectives, as well as compliance with applicable business and regulatory requirements.
-Work with teams to implement quality systems and improvements that meet local business and regulatory requirements.
-Responsibilities include administration and management of the Electronic Document Management System (EDMS), Electronic Quality Management System (EQMS), Learning Management System (LMS), as well as extended support and oversight of other GxP systems.
GENERAL DUTIES:
-Ensure the following key areas of GxP computerized system governance are established and maintained for applicable systems
-Management: Validation planning, supplier assessment, risk management
-Development
1. Validation approach & deliverables – maintain current “as is” validation state
2. Configuration and design
3. Management, development, testing, and review of software
4. Data management
-Operation
1. Support services, performance monitoring, incident management, security, training, user authorizations
2. CAPA, change management, updates/patches, repair activity
3. Data integrity, periodic review, backup and restore, business continuity
-Quality lead on designated Computer Systems implementations, ensuring all regulatory and compliance issues are addressed and documented
-Mentor staff working on GxP computer system validation
-Lead and support improvement projects to solve problems, enhance system capabilities, and expand use of GxP systems to new sites and functional areas in need.
-Work with relevant teams to maintain capabilities for collecting and reporting Quality data and projects, including maintaining Quality SharePoint Portals where necessary.
-Participate in internal and supplier audits as requested.
-Participate in improvement initiatives and programs as requested.
-Stay current with GxP and industry standards
QUALIFICATIONS:
-Bachelor’s degree in pharmacy or life science, or higher degree, with the right combination of extensive experience and success in the pharmaceutical industry
-Education in computer science, coding or programming is a benefit
-Thorough knowledge of pharmaceutical industry, quality systems, computerized system validation, GAMP 5, and relevant GxP and data integrity requirements.
-Experience and skills related to the operation, administration, and overall governance of GxP computer systems and software applications.
-Working knowledge of help desk software/support, databases, SaaS, and analytical reporting
-Strong technical background and ability to explain complex information in simple, clear terms to non-IT personnel. Ability to assess customers IT knowledge and provide appropriate support.
-Proven track record of successful GxP Computer System implementations and governance.
-More than 10 years’ experience in different quality related roles within the pharmaceutical industry
-Good knowledge and experience in Project Management principles and techniques.
-Thorough knowledge of Quality Systems and risk-based decision making.
-Experience dealing directly with regulatory agencies
-Experience and skills in operating across and between different national cultures.
-Good command of Mandarin and English
SKILLS:
-Strong leadership/team management skills
-Credible and confident communicator with good presentation skills (written and verbal).
-Strategic thinker with the ability to influence at all levels
-Strong analytical and problem-solving ability, including identifying potential solutions, recommending and implementing methods, procedures and/or techniques for resolution.
-Able to work proactively and independently.
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